Status:

RECRUITING

Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

Lead Sponsor:

Chengdu University of Traditional Chinese Medicine

Conditions:

Varicose Veins of Lower Limb

Venous Insufficiency of Leg

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

Objective: To investigate the clinical efficacy of ultrasound-guided radiofrequency ablation and microwave ablation in the treatment of primary saphenous varicose veins.

Detailed Description

Chronic venous insufficiency (CVI) is a common clinical disease, and varicose veins of the lower extremities are the main clinical manifestations of CVI, and studies have shown that the prevalence of ...

Eligibility Criteria

Inclusion Criteria:

  • Age ≥18 years and ≤90 years;
  • Clinical diagnosis of primary varicose veins of the lower extremities, CEAP clinical classification C2-C6, requiring treatment of the great and/or small saphenous vein segments, and at least 1 of the clinical symptoms of swelling, pain, burning sensation, heaviness, easy fatigue, itchy skin, and night cramps;
  • Valve insufficiency of the great saphenous vein, small saphenous vein, or transport vein;
  • Doppler ultrasound confirmation of a saphenous vein diameter greater than 3 mm and less than 12 mm in the standing position;
  • Only one limb per patient was selected for inclusion in the study;
  • Patients signed an informed consent form and were willing to co-operate in completing the protocol-specified investigations and follow-up visits.

Exclusion Criteria:

  • Thrombosis of the great saphenous or small saphenous vein, or combined deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism.
  • Recurrent varicose veins after previous treatment.
  • Severe distortion of the great saphenous vein with anticipated catheter failure.
  • Severe lower limb ischaemia (CLI) (ABPI <0.8).
  • Known allergy to medications and device materials involved in the study.
  • Pre-existing implanted pacemaker, defibrillator, currently on regular anticoagulation therapy (e.g., warfarin, heparin).
  • Women who are pregnant or breastfeeding.
  • Unable or unwilling to complete the questionnaire.
  • Participating in a study of another drug or device.
  • Life expectancy <1 year.
  • Those undergoing treatment for skin malignancies other than non-melanoma.
  • Daily use of narcotic drugs or non-steroidal anti-inflammatory drugs to control pain due to venous disease.
  • In the judgement of the investigator, endovenous therapy is not appropriate.

Key Trial Info

Start Date :

December 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06711120

Start Date

December 1 2024

End Date

December 1 2025

Last Update

December 2 2024

Active Locations (1)

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1

Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, China